EVarQuit: Extinguishing cigarette smoking via extended pre-quit varenicline

EVarQuit：通过延长戒烟前伐尼克兰来戒烟

• 批准号: 10055954
• 负责人: LARRY W HAWK
• 金额: $ 61.05万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10055954
• 关键词: Abstinence; Adult; Agonist; Animal Experimentation; Behavioral; Binding; Biochemical; Biological; Cause of Death; Cessation of life; Cigarette; Clinical; Clinical Data; Cotinine; Counseling; Data; Development; Dissemination and Implementation; Dopamine; Ecological momentary assessment; Exhibits; Expectancy; Extinction (Psychology); Female; Frequencies; Gender; Goals; Hawks; Human; Individual; Label; Laboratories; Learning; Life; Link; Longterm Follow-up; Malignant Neoplasms; Measures; Mediating; Mediation; Methods; Morbidity - disease rate; Nausea; Nicotine; Nicotinic Receptors; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Physicians; Physiological; Placebos; Process; Psychological reinforcement; Public Health; Randomized; Randomized Clinical Trials; Rattus; Relapse; Research; Research Support; Running; Self Administration; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Testing; Time; Withdrawal; Woman; Work; base; cancer prevention; cigarette smoke; cigarette smoking; clinical efficacy; clinical practice; cost; craving; efficacy testing; follow-up; improved; mortality; next generation; nicotine exposure; novel therapeutics; pre-clinical; predictive modeling; primary outcome; smoking cessation; success; theories; varenicline

PROJECT SUMMARY/ABSTRACT Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer duration of varenicline treatment prior to the target quit date (TQD) will yield greater decreases in the number of cigarettes smoked per day before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on our promising preliminary clinical data, we propose to test these hypotheses with a full-scale randomized clinical trial (RCT). Four hundred treatment-seeking smokers (200 female) will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit) and at long-term follow-up (weeks 8-26 and 8-52 post-quit). Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by converging behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). We predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. We further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: We aim to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.

项目摘要/摘要 Varenicline是可用的最有效的戒烟疗法。尽管如此，大多数 吸烟者在退出后的头几个月内使用Varenicline复发。 varenicline是 假设可以通过减少吸烟的增强作用来帮助吸烟者戒烟 在标准的1周预引诱治疗阶段。学习理论和以前的人 动物研究支持以下假设：较长的varenicline治疗持续时间 到目标退出日期（TQD）将在抽烟的数量中增加更多的减少 与标准Varenicline相比，退出前一天和更高的长期停止率 治疗。在我们有希望的初步临床数据的基础上，我们建议对这些 具有全尺度随机临床试验（RCT）的假设。四百个寻求治疗 吸烟者（200名女性）将被随机分为标准磨合组（安慰剂3周， 其次是TQD Varenicline的标准1周）或延长的磨合组（4周 pre-tqd varenicline）。两组将获得简短的个人戒烟咨询和11 TQD后Varenicline的几周。主要结果指标将是生物验证的连续 禁止治疗结束时（提示后第8-11周）和长期随访（第8-26周） 和8-52后）。假设的中介机制（例如，吸烟加强）将是 通过收敛的行为，生理和主观措施进行评估 实验室并使用现实世界，实时电子瞬时评估（EMA）。我们预测 长期，生物验证的戒烟将在扩展的磨合组中得到改善 与标准磨合组相比。我们进一步预测了与 将通过更大的预先减少来解释（或调解）扩展的磨合量。 与标准磨合相比，扩展的磨合组中的吸烟加强 团体。这项工作的重要性很明显：我们旨在为 使用一种已经成熟的传播和方法的方法，戒烟甚至更好 这将阐明关键机制在下一代治疗中靶向 增强。

项目成果

The Perceived Impact of COVID-19 among Treatment-Seeking Smokers: A Mixed Methods Approach.

• DOI: 10.3390/ijerph18020505
• 发表时间: 2021-01-09
• 期刊: International journal of environmental research and public health
• 作者: Rosoff-Verbit Z;Logue-Chamberlain E;Fishman J;Audrain-McGovern J;Hawk L;Mahoney M;Mazur A;Ashare R
• 通讯作者: Ashare R

Withdrawal Symptom, Treatment Mechanism, and/or Side Effect? Developing an Explicit Measurement Model for Smoking Cessation Research.

戒断症状、治疗机制和/或副作用？

• DOI: 10.1093/ntr/nty262
• 发表时间: 2020
• 期刊: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco
• 作者: Tonkin,SarahS;Williams,TrevorF;Simms,LeonardJ;Tiffany,StephenT;Mahoney,MartinC;Schnoll,RobertA;Cinciripini,PaulM;Hawk,LarryW
• 通讯作者: Hawk,LarryW

Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial.

• DOI: 10.1001/jamanetworkopen.2022.41731
• 发表时间: 2022-11-01
• 期刊: JAMA NETWORK OPEN
• 影响因子: 13.8
• 作者: Hawk, Larry W., Jr.;Tiffany, Stephen T.;Colder, Craig R.;Ashare, Rebecca L.;Wray, Jennifer M.;Tyndale, Rachel F.;Brandon, Thomas H.;Mahoney, Martin C.
• 通讯作者: Mahoney, Martin C.

Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline.

戒烟药物副作用的基因预测：瓦尼克兰异常梦的全基因组研究。

• DOI: 10.1002/cpt.3210
• 发表时间: 2024
• 期刊: Clinical pharmacology and therapeutics
• 影响因子: 6.7
• 作者: Chenoweth,MeghanJ;Kim,YongJae;Nollen,NikkiL;HawkJr,LarryW;Mahoney,MartinC;Lerman,Caryn;Knight,Jo;Tyndale,RachelF
• 通讯作者: Tyndale,RachelF

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

评估伐尼克兰的治疗机制：通过情感和渴望进行调节。

• DOI: 10.1093/ntr/ntac138
• 发表时间: 2022
• 期刊: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco
• 作者: Tonkin,SarahS;Colder,Craig;Mahoney,MartinC;Swan,GaryE;Cinciripini,Paul;Schnoll,Robert;George,TonyP;Tyndale,RachelF;Hawk,LarryW
• 通讯作者: Hawk,LarryW